Korea Regulatory Coverage Across the MedTech Spectrum
From AI diagnostics to active implantables to traditional hardware, Leanabl supports foreign manufacturers across every major MFDS device category. The three archetypes below describe how our engagement adapts to your device type.
SaMD (Software as a Medical Device)
Korean Regulatory Pathways for Software & AI Medical Devices
From AI-powered diagnostics to digital therapeutics, we manage MFDS classification, Korean technical-file authoring, cybersecurity submission, and Digital Medical Products Act alignment — so your software passes Korean review at the first attempt.
Regulatory Focus
We turn your global software file into a Korea-ready submission.
AIMD (Active Implantable Medical Devices)
MFDS Registration for Life-Sustaining Implants
For the highest-risk devices — pacemakers, neurostimulators, cochlear implants — we manage MFDS Class III/IV registration, foreign-manufacturer KGMP certification, and the clinical evidence dossiers Korean review requires.
Regulatory Focus
We carry the highest-risk submissions through MFDS scrutiny — predictably and on schedule.
Medical Devices & IVD
MFDS Registration & KGMP Across Hardware and In-Vitro Diagnostics
For hardware devices and in-vitro diagnostics, we manage MFDS product licensing (Class I–IV), KGMP certification, HIRA reimbursement listing, and ongoing KLH operations — covering every regulatory function a foreign manufacturer needs in Korea.
Regulatory Focus
One in-country team across the full Korean regulatory lifecycle.
One Partner. Every MedTech Sector. End-to-End Korea Coverage.
Whatever your device type, the path through MFDS, KGMP, KLH, and HIRA runs through Korea-resident teams who own the submission from filing to issuance — and stay accountable through post-market.
Related resources
IMDRF Publishes AIMD Risk Categorization Framework — January 2026
International Medical Device Regulators Forum (IMDRF) published its Active Implantable Medical Device (AIMD) risk categorization framework in January 2026, harmonizing global regulatory approaches to AIMD classification.
22 Jan 2026
Korea SaMD Approval Pathway for AI/ML Medical Devices
MFDS approves AI/ML-based Software as a Medical Device under a hybrid framework. A practical guide to classification, clinical evidence, and post-market change control.
19 May 2026
How a Korean Digital Health Startup Cleared MFDS SaMD Pathway in 5 Months
A Korean AI radiology startup achieved MFDS Class III SaMD approval in 5 months — faster than the typical 8–14 month timeline. Here's how the strategy worked.
20 Apr 2026